Clomipramine hydrochloride - Generic Drug Details

What are the generic drug sources for clomipramine hydrochloride and what is the scope of patent protection?

Clomipramine hydrochloride is the generic ingredient in two branded drugs marketed by Specgx Llc, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma, Chartwell Rx, Chemistry Hlth, Jubilant Cadista, Lupin Ltd, Mankind Pharma, Micro Labs, Mylan, Rk Pharma, Sandoz, Taro, Teva, Trupharma, Unique, Watson Labs, and Zydus Pharms, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for clomipramine hydrochloride. Twenty-four suppliers are listed for this compound.

Summary for clomipramine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	20
NDAs:	22
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	23
What excipients (inactive ingredients) are in clomipramine hydrochloride?	clomipramine hydrochloride excipients list
DailyMed Link:	clomipramine hydrochloride at DailyMed

Recent Clinical Trials for clomipramine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Roma La Sapienza	Phase 3
Fidia Farmaceutici s.p.a.	Phase 4
Assiut University	Phase 3

See all clomipramine hydrochloride clinical trials

Pharmacology for clomipramine hydrochloride

Drug Class

Tricyclic Antidepressant

Medical Subject Heading (MeSH) Categories for clomipramine hydrochloride

Antidepressive Agents, Tricyclic

Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for clomipramine hydrochloride

N06AA	Non-selective monoamine reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for clomipramine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	CAPSULE;ORAL	216440-003	Mar 20, 2023	AB	RX	No	No
Zydus Pharms	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	CAPSULE;ORAL	208961-002	Dec 27, 2017	AB	RX	No	No
Aurobindo Pharma	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	CAPSULE;ORAL	216440-002	Mar 20, 2023	AB	RX	No	No
Ajanta Pharma Ltd	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	CAPSULE;ORAL	213897-001	Oct 2, 2020	AB	RX	No	No
Chemistry Hlth	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	CAPSULE;ORAL	211364-003	Feb 7, 2020	AB	RX	No	No

Clomipramine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Clomipramine Hydrochloride

Market Overview

Clomipramine hydrochloride, a tricyclic antidepressant, is primarily used for the treatment of obsessive-compulsive disorder (OCD) and other psychiatric conditions. The market for clomipramine is expected to experience significant growth over the forecast period of 2022-2029.

Market Growth Drivers

• Increasing Prevalence of OCD and Other Psychiatric Disorders: The rise in the prevalence of OCD and other conditions such as depression, panic attacks, and schizophrenia is a major driver for the expansion of the clomipramine market. This increasing demand is fueled by the growing awareness and diagnosis of these disorders[1][4].
• Aging Population: The increasing geriatric population is another significant factor, as older adults are more likely to suffer from psychiatric disorders that require treatment with clomipramine[1].
• Research and Development: Ongoing research and development activities, including clinical trials, are expected to provide beneficial opportunities for the clomipramine market. These efforts aim to improve the efficacy and safety of the drug[1][4].
• Healthcare Expenditure: Rising healthcare expenditure and increasing government support, particularly in regions like Asia-Pacific, are also driving the market growth[1].

Market Segmentation

The clomipramine market is segmented based on several factors, including:

• Strength: Available in various strengths such as 10mg, 25mg, 50mg, and 75mg[1].
• Application: Used for treating OCD, depression, panic attacks, schizophrenia, Tourette syndrome, and other conditions[1][2].
• Demographic: Categorized into adult, pediatric, and geriatric populations[1].
• Dosage Form: Available in tablet and capsule forms[1].
• Route of Administration: Primarily administered orally[1][2].
• End-Users: Clinics, hospitals, and other healthcare facilities[1].
• Distribution Channel: Distributed through hospital pharmacies, retail pharmacies, and online pharmacies[1].

Regional Analysis

• North America: This region dominates the clomipramine market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure[1].
• Asia-Pacific: Expected to grow significantly during the forecast period due to increasing research and development activities and growing government support[1].

Financial Trajectory

The clomipramine market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.40% from 2022 to 2029. This growth is driven by the increasing demand for antidepressants, rising healthcare expenditure, and growing awareness about psychiatric disorders[1].

Competitive Landscape

The competitive landscape of the clomipramine market includes details about company overviews, financials, revenue generated, market potential, investment in research and development, and global presence. Key players are focusing on new market initiatives, product launches, and clinical trials to maintain their market position[1][4].

Challenges and Limitations

Despite the positive growth trajectory, the clomipramine market faces several challenges:

• High Cost and Side Effects: The high cost of the drug and its associated side effects, such as nausea, headache, drowsiness, and seizures, can hamper market growth. These side effects may lead to a decrease in patient compliance and overall market demand[1][5].
• Lack of Awareness: Limited awareness about the benefits and risks of clomipramine, especially in certain regions, can further challenge the market growth[1].

Pharmacokinetics and Safety Considerations

Understanding the pharmacokinetics of clomipramine is crucial for its safe and effective use. The drug is metabolized primarily through the liver via CYP450 enzymes, and its half-life ranges from 19 to 37 hours. The metabolism and elimination of clomipramine can be capacity-limited, leading to potential accumulation and increased risk of adverse effects, including seizures[2][5].

Drug-Drug Interactions

Clomipramine interacts with various drugs, including hepatic enzyme inhibitors and inducers, which can affect its plasma levels and therapeutic efficacy. For example, co-administration with haloperidol can increase plasma concentrations of clomipramine, while hepatic inducers like barbiturates can reduce its plasma levels[2][5].

Key Takeaways

• The clomipramine market is expected to grow at a CAGR of 4.40% from 2022 to 2029.
• The market is driven by increasing prevalence of OCD and other psychiatric disorders, an aging population, and rising healthcare expenditure.
• North America dominates the market, while Asia-Pacific is expected to show significant growth.
• High cost and side effects, along with lack of awareness, are major challenges.
• Understanding pharmacokinetics and drug-drug interactions is crucial for safe and effective use.

FAQs

1. What is clomipramine hydrochloride used for? Clomipramine hydrochloride is primarily used for the treatment of obsessive-compulsive disorder (OCD) and other psychiatric conditions such as depression, panic attacks, and schizophrenia[1][2].

2. What are the common side effects of clomipramine? Common side effects include nausea, headache, drowsiness, dry mouth, constipation, and urinary retention. Life-threatening side effects can include arrhythmia, tachycardia, QTc prolongation, and seizures[2][5].

3. How is clomipramine metabolized? Clomipramine is metabolized primarily through the liver via CYP450 enzymes, specifically CYP450 2D6 and CYP450 1A2, into its active metabolite desmethylclomipramine[5].

4. What are the key drivers of the clomipramine market? The key drivers include the increasing prevalence of OCD and other psychiatric disorders, an aging population, rising healthcare expenditure, and ongoing research and development activities[1][4].

5. What are the potential challenges for the clomipramine market? High cost, side effects, and lack of awareness are significant challenges that can hamper the market growth[1].

Sources

1. Data Bridge Market Research: Global Clomipramine Market - Industry Trends and Forecast to 2029.
2. FDA: Anafranil™ (clomipramine hydrochloride) Capsules USP.
3. NCBI Bookshelf: Clomipramine - StatPearls.
4. GII Research: Global Clomipramine Market Insights, Forecast to 2029.
5. NCBI: Clomipramine – StatPearls - National Institutes of Health (NIH).